Notice2024-01589
Conducting Remote Regulatory Assessments-Questions and Answers; Revised Draft Guidance for Industry; Availability
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
January 26, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability for comment of a revised draft guidance for industry entitled "Conducting Remote Regulatory Assessments--Question and Answers." FDA has revised and is reissuing the draft guidance in response to public comments and recent amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act). When finalized, this guidance will describe FDA's current thinking regarding its use of remote regulatory assessments (RRAs). FDA has used RRAs to conduct oversight, mitigate risk, meet critical public health needs, and help maximize compliance of FDA-regulated products. This revised draft guidance provides answers to frequently asked questions regarding RRAs.
Full Text
<html>
<head>
<title>Federal Register, Volume 89 Issue 18 (Friday, January 26, 2024)</title>
</head>
<body><pre>
[Federal Register Volume 89, Number 18 (Friday, January 26, 2024)]
[Notices]
[Pages 5244-5246]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-01589]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-D-0810]
Conducting Remote Regulatory Assessments--Questions and Answers;
Revised Draft Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability for comment of a revised draft guidance for industry
entitled ``Conducting Remote Regulatory Assessments--Question and
Answers.'' FDA has revised and is reissuing the draft guidance in
response to public comments and recent amendments to the Federal Food,
Drug, and Cosmetic Act (FD&C Act). When finalized, this guidance will
describe FDA's current thinking regarding its use of remote regulatory
assessments (RRAs). FDA has used RRAs to conduct oversight, mitigate
risk, meet critical public health needs, and help maximize compliance
of FDA-regulated products. This revised draft guidance provides answers
to frequently asked questions regarding RRAs.
DATES: Submit either electronic or written comments on the draft
guidance by March 26, 2024 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.
ADDRESSES: You may submit comments on any guidance at any time as
follows:
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
<bullet> Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
<bullet> For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2022-D-0810 for ``Conducting Remote Regulatory Assessments;
Questions and Answers; Guidance for Industry.'' Received comments will
be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available
[[Page 5245]]
for public viewing and posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Submit
both copies to the Dockets Management Staff. If you do not wish your
name and contact information to be made publicly available, you can
provide this information on the cover sheet and not in the body of your
comments and you must identify this information as ``confidential.''
Any information marked as ``confidential'' will not be disclosed except
in accordance with 21 CFR 10.20 and other applicable disclosure law.
For more information about FDA's posting of comments to public dockets,
see 80 FR 56469, September 18, 2015, or access the information at:
<a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single copies of the draft guidance to
the Division of Operational Policy, Office of Regulatory Affairs, Food
and Drug Administration, Element Building, 12420 Parklawn Dr.,
Rockville, MD 20852. Send one self-addressed adhesive label to assist
the office in processing your requests. The draft guidance may also be
obtained by mail by emailing ORA at <a href="/cdn-cgi/l/email-protection#3758455647585b5e544e44435651514477515356195f5f4419505841"><span class="__cf_email__" data-cfemail="d8b7aab9a8b7b4b1bba1abacb9bebeab98bebcb9f6b0b0abf6bfb7ae">[email protected]</span></a>. See
the SUPPLEMENTARY INFORMATION section for electronic access to the
draft guidance document.
FOR FURTHER INFORMATION CONTACT: Ben Firschein, Office of Regulatory
Affairs, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
32, Silver Spring, MD 20993-0002, <a href="/cdn-cgi/l/email-protection#cc8ea9a2e28aa5bebfafa4a9a5a28caaa8ade2a4a4bfe2aba3ba"><span class="__cf_email__" data-cfemail="80c2e5eeaec6e9f2f3e3e8e5e9eec0e6e4e1aee8e8f3aee7eff6">[email protected]</span></a>, 240-402-
0613; or Patrick Clouser, Office of Regulatory Affairs, Food and Drug
Administration, Element Building, 12420 Parklawn Dr., Rockville, MD
20857, <a href="/cdn-cgi/l/email-protection#3868594c4a515b53167b54574d4b5d4a785e5c591650504b165f574e"><span class="__cf_email__" data-cfemail="52023326203b31397c113e3d27213720123436337c3a3a217c353d24">[email protected]</span></a>, 240-402-5276.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a revised draft guidance for
industry entitled ``Conducting Remote Regulatory Assessments--Questions
and Answers.'' This draft revises the draft guidance entitled
``Conducting Remote Regulatory Assessments--Questions and Answers;
Draft Guidance for Industry,'' which was announced in the Federal
Register on July 25, 2022 (87 FR 44129) (hereafter, the ``original
draft guidance''). FDA issued the original draft guidance to describe
the Agency's thinking regarding its use of RRAs, to help increase the
industry's understanding of voluntary and mandatory RRAs, and to
facilitate FDA's process for conducting remote assessments for all
types of FDA-regulated products outside of the COVID-19 public health
emergency. The comment period for the original draft guidance ended on
September 23, 2022.
One of the mandatory RRAs FDA discussed in the original draft
guidance was the requirement that establishments engaged in
manufacturing, preparing, propagating, compounding, or processing drugs
produce, upon request from FDA, records or other information by in
advance of or in lieu of an inspection, under section 704(a)(4) of the
FD&C Act.
In the revised draft guidance we have clarified our answers to
questions regarding: (1) the benefits of an RRA, and any consequences
for not participating; (2) how a facility will know an RRA is being
requested, and whether it is mandatory or voluntary; (3) when and how
FDA may initiate an RRA; (4) how FDA may conduct RRAs in relation to
FDA inspections or to activities by state and foreign regulatory
partners; (5) what an establishment should expect during an RRA,
including overall process and technological expectations, and how
consent may be established for a voluntary RRA; (6) how FDA will seek
to provide for ongoing communication between FDA and an establishment;
and (7) what may occur upon the completion of an RRA.
The revised draft guidance also contains revisions to align with
recent changes to section 704(a)(4) of the FD&C Act made by the Food
and Drug Omnibus Reform Act of 2022 (FDORA).\1\ Specifically, FDORA
amended section 704(a)(4) of the FD&C Act in several ways:
---------------------------------------------------------------------------
\1\ On December 29, 2022, the President signed into law FDORA,
which was enacted as part of the Consolidated Appropriations Act,
2023, Public Law 117-328 (2022).
---------------------------------------------------------------------------
1. FDORA sections 3611(b)(1)(A) and 3612(a) expanded those subject
to mandatory requests for records or other information under section
704(a)(4) of the FD&C Act to include: (a) establishments that engage in
the manufacture, preparation, propagation, compounding, or processing
of a device, and (b) sites or facilities that are subject to inspection
under section 704(a)(5)(C) (i.e., bioresearch monitoring inspections)
(21 U.S.C. 374(a)(5)).
2. FDORA section 3611(b)(1)(B) added a requirement that FDA provide
a rationale for requesting records or other information under section
704(a)(4) of the FD&C Act.
3. FDORA section 3613(b) inserted new section 704(a)(4)(C) of the
FD&C Act providing that FDA may rely on any records or other
information obtained under section 704(a)(4) to satisfy requirements
that may pertain to a preapproval or risk-based inspection, or to
resolve deficiencies identified during such inspections, if applicable
and appropriate.
4. FDORA required FDA to issue or update guidance describing the
circumstances under which the Agency intends to use its authority to
issue requests for records or other information under section 704(a)(4)
of the FD&C Act (as amended by FDORA), the processes for firms to
respond, and the factors for determining whether a facility has
appropriately and timely responded (FDORA section 3611(b)(2)).
FDA seeks public comment on the revised draft guidance. We are
particularly interested in receiving comments that relate to revisions
the Agency is proposing to address the above FDORA requirements.
This revised draft guidance is being issued consistent with FDA's
good guidance practices regulation (21 CFR 10.115). The draft guidance,
when finalized, will represent the current thinking of FDA on
``Conducting Remote Regulatory Assessments.'' It does not establish any
rights for any person and is not binding on FDA or the public. You can
use an alternative approach if it satisfies the requirements of the
applicable statutes and regulations.
II. Paperwork Reduction Act of 1995
FDA tentatively concludes that this revised draft guidance contains
no collection of information. Therefore, clearance by the Office of
Management and Budget under the Paperwork Reduction Act of 1995 is not
required.
III. Electronic Access
Persons with access to the internet may obtain the revised draft
guidance at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, <a href="https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs">https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs</a>, or <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
[[Page 5246]]
Dated: January 23, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-01589 Filed 1-25-24; 8:45 am]
BILLING CODE 4164-01-P
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on January 26, 2024.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.